EUCTR2005-001951-39-DE进行中（未招募）不适用
A Phase II study of oral gimatecan (ST 1481) as salvage treatment in patients with advanced or metastatic soft tissue sarcoma relapsing after anthracycline/ifosfamide-based chemotherapy regimen
Sigma Tau Industrie Farmaceutiche Riunite S.p.A.0 个研究点目标入组 84 人开始时间: 2005年10月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Soft Tissue Sarcoma relapsing after anthracyclines and ifosfamide based chemotherapy.
- •Only the following subtypes of soft tissue sarcoma should be included: Fibrosarcoma
- •Leiomyosarcoma
- •Liposarcoma
- •Malignant fibrous histiocytoma
- •Rhabdomyosarcoma
- •Ewing’s Sarcoma of Soft Tissue Synovial sarcoma
- •Angiosarcoma/hemangiopericytoma
- •Malignant peripheral nerve sheath tumor (MPNST)
- •Sarcoma - unclassified
- •Mesenchymal chondrosarcoma
- •Extraskeletal myxoid chondrosarcoma (provided that it is metastatic disease which cannot be surgically treated)
- •2. Patients must have received previous chemotherapy regimens for unresectable advanced or metastatic disease, including anthracyclines and ifosfamide. A maximum of three prior lines is permitted (including adjuvant). Anthracyclines and ifosfamide may have been administered simultaneously or in successive lines of therapy, but the patient should have received both.
- •3. Clear progressive disease. In case of prior adjuvant therapy progression should have occurred during adjuvant therapy or within 24 months of completion of adjuvant therapy.
- •4. Age > 18 years.
- •5. ECOG performance status < 1.
- •6. Adequate hematological function: hemoglobin > 9 g/dl; neutrophils > 1.5 x 109/L; platelets > 150 x 109/L;
- •7. LVEF > 50% evaluated by means of ultrasound
- •8. Adequate liver and renal function
- •- alkaline phosphatase £ 1.5 x UNL, if bone metastases present, hepatic isoenzyme should be <1.5 UNL
- •- total serum bilirubin £ 1.5 times UNL regardless of liver involvement secondary to tumor
- •- ALT, AST £ 1.5 x UNL (£ 2.5 x UNL in presence of liver metastases)-albumin > 2.5 g/dl
- •- creatinine £ 1.5mg/dL
- •9. All previous therapies to treat sarcoma must have been discontinued > 4 weeks before study entry and all acute toxicities (excluding alopecia) of any prior therapy must have resolved to CTCAE (Version 3.0) Grade =1.
- •10. Life expectancy of at least 3 months.
- •11. Evidence of a signed and dated informed consent document indicating the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
- •12. Willingness and ability to comply with the study protocol for the duration of the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The following sarcomas are NOT eligible:
- •- Gastrointestinal stromal sarcoma (GIST)
- •- Osteosarcoma of soft tissue
- •- Chondrosarcoma (with the exception of mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma (metastatic disease which cannot be surgically treated)))
- •- Carcinosarcomas (mixed Mullerian tumors)
- •- Kaposi sarcoma
- •- Malignant mesothelioma
- •- Clear cell sarcoma
- •2. Prior radiation therapy to > 30% red bone marrow
- •3. Active infection.
- •4. Any investigational agent received = 4 weeks prior to study entry and/or concurrent enrolment in another clinical trial.
- •5. Any prior topotecan- or irinotecan - containing regimen or any regimen containing an investigational inhibitor of topoisomerase I.
- •6. Prior high dose chemotherapy treatment requiring hematopoietic stem cell rescue.
- •7. Previous major gastrointestinal surgery or diseases that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, known intolerance to lactose, malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
- •8. Inability to swallow
- •9. Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
- •10. Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- •11. Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years.
- •12. Symptomatic brain metastases or leptomeningeal disease requiring therapy.
- •13. Pregnancy or lactation or unwillingness to use adequate method of birth control
研究者
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